Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 690517 in Healthy Male Subjects (Single-blind, Partially Randomised, Placebo-controlled Within Dose Groups) and Effect of Food on the Bioavailability of BI 690517 (Openlabel, Randomised, Two-way Cross-over)

Boehringer Ingelheim1 site in 1 country72 target enrollmentMay 5, 2017

ConditionsHealthy

InterventionsBI 690517 Placebo BI 690517 (Reference)

DrugsBI 690517 Placebo BI 690517 (Reference)

Overview

Phase: Phase 1
Intervention: BI 690517
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Enrollment: 72
Locations: 1
Primary Endpoint: [N (%)] of subjects with drug-related Adverse Events
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of the trial is to investigate the safety and tolerability of BI 690517 in healthy male subjects following oral administration of multiple rising doses over 14 days (MRD part).

Secondary objectives for the MRD part are the exploration of PK (Pharmacokinetic(s)), including dose proportionality, as well as investigation of linearity and PD (Pharmacodynamic(s)) of BI 690517 after multiple dosing.

For the FE (food effect) part, the secondary objective is to investigate the relative bioavailability of BI 690517 under fasted conditions (Reference, R) compared to BI 690517 (single dose) after a high fat high caloric breakfast (Test, T).

Registry

clinicaltrials.gov

Start Date

May 5, 2017

End Date

November 24, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP(Blood Pressure), PR (Pulse Rate)), 12-lead ECG (Electrocardiogram), and clinical laboratory tests
•Age of 18 to 50 years (incl.)
•BMI(Body Mass Index) of 18.5 to 29.9 kg/m2 (incl.)
•Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and local legislation
•Willingness to comply with contraception requirements. Subjects who are sexually active must use adequate contraception with their female partner throughout the study and until one month after the last administration of trial medication. Adequate methods are:
•Sexual abstinence or
•A vasectomy performed at least 1 year prior to screening in combination with a barrier method (condom) or
•Surgical sterilisation (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy) of the subject's female partner or
•The use of condoms, if the female partner uses an adequate contraception method in addition, e.g., intrauterine device (IUD), hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 months prior to first drug administration, or barrier method (e.g. diaphragm with spermicide) Unprotected sexual intercourse with a female partner is not allowed throughout the study and until one month after the last administration of trial medication.

Exclusion Criteria

•Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
•Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
•Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
•Any evidence of a concomitant disease judged as clinically relevant by the investigator
•Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
•Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
•Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
•History of relevant orthostatic hypotension, fainting spells, or blackouts; orthostatic dysregulation identified during screening or on Day 1)
•Chronic or relevant acute infections
•History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients or Synacthen®), previous diagnostic test with Synacthen®

Arms & Interventions

Dose Ranging Arm

Intervention: BI 690517

Dose Ranging Arm

Intervention: Placebo

Food Effect arm

Intervention: BI 690517 (Reference)

Food Effect arm

Intervention: BI 690517

Outcomes

Primary Outcomes

[N (%)] of subjects with drug-related Adverse Events

Time Frame: Day 30

\[N (%)\] of subjects with drug-related Adverse Events

Secondary Outcomes

AUCtau,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval tau after administration of the first dose [AUCtau,1 will be AUC0-24])(0-24 hours)
Cmax (maximum measured concentration of the analyte in plasma) (After the first dose)(Multiple rising dose part)(up to 24 hours)
AUCtau,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval tau)(After the last dose)(Multiple rising dose part)(312 - 360 hours)
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval tau)(After the last dose)(Multiple rising dose part)(after 312 hours and up to 360 hours)
Cmax (maximum measured concentration of the analyte in plasma) (Food effect part)(Up to 48 hours)
AUC0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(Up to 48 hours)
AUC0- tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)(Up to 48 hours)